OPTEL’s Serialization Software to Meet 2019 DSCSA Saleable Returns Requirements

While most everyone knows that November 2018 is the deadline for item-level serialization under the U.S. Food and Drug Administration’s Drug Supply Chain Security Act (DSCSA), some may not be aware that the DSCSA saleable-returns verification process becomes effective November 27, 2019. After that date, wholesale distributors must trade only in serialized product; in fact, the “Big 3” distributors (AmerisourceBergen, Cardinal Health and McKesson) have clearly indicated that they will not accept products that are not serialized. The only exceptions are products that meet the FDA’s grandfathering guidelines.

In addition, the Big 3 have indicated they will not accept non-serialized returned products, also known as saleable returns. According to a recent letter circulated by AmerisourceBergen, its 450+ manufacturing trading partners generate an estimated $13M+ annual saleable returns, which underscores the magnitude of the saleable-return verification process. Unfortunately, there is no single, industry-wide solution for compliance with the 2019 saleable-returns requirements.

However, pharma organizations do have options, based on recommendations set forth by the HDA Saleable Returns Pilots. In separate letters, the three largest pharma distributors have indicated that they will support the following options:

  1. Manufacturers can send aggregated serialized data with each shipment so product identifiers can be verified internally. This scenario requires aggregation and serialized data exchange via EPCIS (1.1, 1.2). Pharma organizations that choose this option should start sending data to the Big 3 by January 2019 to meet November 2019 self-verification timelines. Because it can take up to 90 days to successfully complete testing, pharma organizations are encouraged to begin the process several months before the target date.
  2. The second scenario involves a Verification Router Service (VRS), in which manufacturers maintain their own database of serial numbers and subscribe to a third-party routing service that manages all requests for verification as well as the manufacturer responses.

While this option has several challenges, there are current projects/pilots underway. The greatest challenges have to do with governance and funding. As such, an industry task force composed of manufacturers, distributors and service providers has been formed to develop the requirements for this system.

 

In its letter to stakeholders, AmerisourceBergen says it will be using the SAP Information Collaboration Hub (SAP ICH) as its VRS provider. It also supports the use of the MediLedger network using blockchain technology as a key enabler of the “lookup” component of its VRS for those not using SAP ICH. Further, the company says it expects all manufacturers or their solution providers to be interoperable with the MediLedger network and aligned with the VRS business requirements developed by the HDA VRS task force. If not, AmerisourceBergen will “reserve the right to return products, or prevent customer returns for products, that cannot be verified due to reoccurring, external, technical or data maintenance issues.”

Because excellent customer support has always been a core value at OPTEL, our Verify Brand® serialization and Track&Trace software will support our customers and their trading partners throughout the saleable-returns verification process. Our standards-based software currently supports all versions of EPCIS and is capable of aggregating serialized data. In addition, our software will have the necessary Application Programming Interface (API) to support a verification routing service well in advance of the Big 3 timelines.

Contact us for a free demonstration of OPTEL’s L4-L5 software for DSCSA compliance.